NCT06107166

Brief Summary

Cardiovascular disease (CVD) is the leading cause of death among women and women with chronic kidney disease are at an even greater risk of CVD. The aim of this observational study is to examine the relationship between total testosterone levels and measures of vascular function (pulse wave velocity, aortic augmentation index, flow mediated dilation and velocity time integral) in reproductive-aged women living with chronic kidney disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
Last Updated

October 30, 2023

Status Verified

October 1, 2023

Enrollment Period

3.1 years

First QC Date

October 24, 2023

Last Update Submit

October 24, 2023

Conditions

Chronic Kidney DiseasesCardiovascular Diseases

Outcome Measures

Primary Outcomes (4)

  • Pulse wave velocity

    Measured at baseline

  • Aortic augmentation index

    Measured at baseline

  • Flow mediated dilation

    Measured at baseline

  • Velocity time integral

    Measured at baseline

Eligibility Criteria

Age18 Years - 51 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population will include stable females of reproductive age (18-51 years of age) with chronic kidney disease. Subjects will require permission of their primary nephrologist or primary care provider to participate

You may qualify if:

  • female sex
  • a diagnosis of chronic kidney disease or end stage kidney disease
  • age 18-51

You may not qualify if:

  • Pregnancy, breastfeeding, current use of menopausal hormone therapy or gender affirming hormone therapy, or factors that would affect ovarian function, such as polycystic ovarian syndrome, premature ovarian insufficiency, ovarian malignancy, gonadotoxic chemotherapy, surgical oophorectomy, or previous radiation to the pelvis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N1N4, Canada

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicCardiovascular Diseases

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 24, 2023

First Posted

October 30, 2023

Study Start

June 1, 2018

Primary Completion

June 30, 2021

Study Completion

December 31, 2021

Last Updated

October 30, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)